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    Company profile for Hetero Drugs

    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    About

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertica...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

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    7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar Hyderabad,Telangana
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    +91 40 23704923/24
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    This week, SpeakPharma interviews four senior executives of LGM Pharma — Shailesh Vengurlekar (Senior VP, Quality and Regulatory Affairs), Deepak Thassu (Senior VP, R&D and Regulatory Submission), Selwyn Lustman (Senior VP, Global Sourcing and Procurement), and Mike Stenberg (VP, Business Development). The four VPs talk about expansion in manufacturing capabilities of the Florida-based contract development and manufacturing organization (CDMO), expertise that makes LGM a strong partner and the criteria it adopts while selecting its suppliers.  HIGHLIGHTS// expansion in manufacturing capabilities/ expertise that makes LGM a strong partner/ criteria for selecting its suppliers LGM Pharma recently invested heavily in expanding its CDMO capabilities by 50 percent. Can you share why offering standalone analytical testing services is important to LGM Pharma’s growth strategy? How does it benefit your clients? Vengurlekar: This recent expansion in CDMO capabilities is part of LGM Pharma’s growth strategy that lays importance on diversification. One key area of this diversification is the offering of standalone Analytical Testing Services (ATS). This service plays a crucial role in supporting our clients by providing them with greater flexibility and reliability. LGM Pharma is already a well-established leader in the API supply chain. We have now identified a significant need in the market and are now serving compounding pharmacies, including 503A and 503B facilities. These pharmacies not only require high-quality, GMP-compliant APIs, but also need a trusted, compliant, and capable laboratory to analyze both their APIs and compounded products. Recognizing this opportunity to further support our clients, LGM Pharma has expanded into ATS. We have witnessed tremendous growth since we’ve launched these services. By offering ATS under a separate legal entity — LGM Pharma Solutions — we are able to provide an additional layer of flexibility to our clients. This structure eliminates any conflict of interest. While LGM Pharma LLC handles API supply, LGM Pharma Solutions focuses on delivering top-tier ATS, all under the same LGM Pharma umbrella. This setup enhances trust and allows our clients to work with us more seamlessly. HIGHLIGHTS// diversified into standalone ATS/ well-established leader in API supply chain/ serving compounding pharmacies/ offering APIs and ATS under different legal entities. While suppositories offer clear advantages for certain medications, can you describe how LGM Pharma plans to leverage its expertise in this area to address specific unmet needs in the growing women’s health market? Thassu: We’re taking a dual approach to enhance both our R&D and manufacturing capabilities. First, we’ve introduced a new semi-automatic machine that allows us to produce smaller batches more efficiently. This is particularly important for the suppository segment, where demand doesn’t require large-scale production. The new system enables quicker adjustments to the manufacturing process, providing us with greater flexibility of producing small batches. Second, many of the materials we handle in the women’s health sector are sensitive to heat, light, and oxygen. To address this, we’re upgrading our facility to accommodate these specialized requirements. This ensures we can develop and manufacture products while maintaining the integrity of heat-, light-, and oxygen-sensitive ingredients. Additionally, we’re working closely with clients to prepare for various technical challenges. Whether it’s processing homeopathic ingredients or handling delicate fermentation-based materials, which are highly sensitive to both light and heat, our team has upgraded its skills and equipment to manage these complexities. From technology advancements in manufacturing to specialized handling conditions and improved technical expertise, we’ve made significant strides to ensure we can meet the evolving needs of our clients and their products. HIGHLIGHTS// dual approach to enhance R&D and manufacturing capabilities/ upgrading facilities to accommodate specialized requirements/ working with clients to address challenges. The pandemic underscored supply chain problems. Can you detail the specific criteria LGM Pharma uses while selecting suppliers for its manufacturing processes? Lustman: LGM looks at many facets of a manufacturer before proceeding to approve them for a specific project. We start by checking their regulatory history with the US Food and Drug Administration (FDA) and other authorities. We try to find out if they have received any warning letters. What is their inspection history? Have they received NAIs (no action indicated) and VAIs (voluntary action indicated)? We further investigate the company’s overall business status — we need to know that they are a stable partner to work with in the long term. Manufacturers are then assessed for their overall technology and the number of employees working in various fields, such as R&D, quality control, quality assurance, regulatory affairs, manufacturing, and the educational levels of these employees. Once we have established that the manufacturer is a potential partner, we check their status for a particular project. We look at their advantages, and whether they have a non-infringing route of synthesis (ROS) that will allow early launch. Are they developing a second process that will be more competitive in pricing? And, does the manufacturer have the necessary capacity and/or spare capacity for the project that we are assessing? We need to know whether the drug master file (DMF) has been registered, the current batch size, and the potential for increase in batch size. Pricing is a key indicator — we need to know whether the pricing of the manufacturer is competitive or not, and if the manufacturer will be able to compete in the future as the project matures. LGM always assesses for quality, price, and delivery. Goods must be of the correct quality, at the right price, with delivery time as desired, in order to meet commercial needs. HIGHLIGHTS// investigate various facets of manufacturer before approving them for a project/ look at advantages, non-infringing ROS/ assess for quality, price, delivery Can you highlight specific capabilities and experiences LGM Pharma possesses that make it a strong partner for companies developing antibody-drug-conjugates (ADCs)? Stenberg: ADCs are often peptides linked with small molecules. However, they may also be peptides linked with oligonucleotides. Regardless, LGM can help manage the supply chain associated with the components that are used in the conjugation of the ADC. LGM has extensive experience, and an extensive network around sourcing and managing the supply chain associated with ADC components. LGM’s experience and capabilities extend to sourcing peptides, small molecules or oligonucleotides used in the conjugation process. Additionally, given our deep relationships in the supply chain aspect of this process, LGM may also be able to identify partners who can help with the conjugation process itself. HIGHLIGHTS// extensive experience, network around sourcing, managing supply chain associated with ADC components / identify partners that can help with conjugation process

    Impressions: 489

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    #SpeakPharma With LGM Pharma
    09 Nov 2024
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    [Sponsored by another company]
    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    This year has seen pivotal advancements in medical innovation. The US Food and Drug Administration (FDA) has approved several groundbreaking therapies that promise to transform patient care across multiple therapeutic areas.Some of the therapies approved have revolutionary delivery mechanisms, while others are first-in-class treatments for previously unaddressed conditions. This week, PharmaCompass brings you a compilation of new pathbreaking approvals of 2024, including advancements in neurology, chronic conditions, mental health conditions, and innovative solutions for various other ailments.Lilly, Alpha Cognition, BMS transform neurological care with new Alzheimer’s, schizophrenia drugsThe neurological treatment landscape saw several major breakthroughs in 2024, particularly in the treatment of Alzheimer’s disease (AD). Eli Lilly’s Kisunla represents a significant advancement in treating early, symptomatic AD. Following decades of failed efforts, Kisunla’s approval, along with that of Eisai-Biogen’s Leqembi last year, marks a turning point in addressing AD.The drug works by targeting and clearing beta amyloid plaque from the brain, thereby attacking the disease’s underlying pathology, rather than just managing symptoms. Administered as an infusion every four weeks, Kisunla’s Medicare coverage makes it accessible to patients in the US who desperately need new treatment options. Alpha Cognition’s Zunveyl emerged as a promising new oral treatment for mild-to-moderate Alzheimer’s-related dementia. Only the second oral AD treatment approved by the FDA in over a decade, Zunveyl is a prodrug, or a biologically inactive compound that can be metabolized by the body to produce a drug. It remains inactive as it passes through the stomach and enhances cholinergic function in the brain.Perhaps one of the most exciting breakthroughs of 2024 was Bristol-Myers Squibb’s Cobenfy. This revolutionary antipsychotic medication for schizophrenia represents the first novel approach to treatment since the 1950s. Unlike traditional antipsychotics that target dopamine receptors, Cobenfy works through cholinergic receptors, offering new hope to patients who struggle with the side effects of conventional treatments.Traditional antipsychotics have been associated with several mild and serious side effects such as weight gain, feeling unmotivated and sluggish, high rates of cardiac disease, and even early death. Cobenfy’s innovative mechanism of action has generated excitement in the medical community. Experts project Cobenfy to bring in US$ 7.5 billion in peak annual sales, thereby validating BMS’ recent, US$ 14-billion acquisition of Karuna Therapeutics.Verona, Sanofi’s drugs revolutionize COPD care; Madrigal’s Rezdiffra offers hope to MASH patients The landscape of chronic obstructive pulmonary disease (COPD) treatment saw remarkable advances in 2024. Verona Pharma’s Ohtuvayre brings the first new mechanism of action in over two decades for COPD treatment. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management.Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Dupixent is Sanofi’s best-selling drug. It is poised to cross over € 21 billion (US$ 23.5 billion) in sales by 2030, with COPD likely to contribute US$ 2.9 billion, predict analysts. Over 390 million people are living with COPD worldwide.In the field of liver disease, Madrigal Pharmaceuticals’ Rezdiffra became the first FDA-approved treatment for metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring. This approval represents a breakthrough in a field that has been notorious for being a graveyard for failed programs. Rezdiffra offers hope to patients with this common liver condition, which primarily affects those with obesity or type 2 diabetes. The American Liver Foundation has termed this approval a “game-changing” moment in hepatology.For the rare disease community, Ipsen’s Iqirvo emerged as the first new medicine approved in nearly a decade for primary biliary cholangitis (PBC). This first-in-class peroxisome proliferator-activated receptor (PPAR) agonist offers new hope for the approximately 100,000 Americans affected by this condition, particularly women aged 30 to 60 years.A significant breakthrough for patients with hypoparathyroidism came with the approval of Ascendis’ Yorvipath, making it the only treatment for hypoparathyroidism in adults. By directly addressing the underlying hormone deficiency, Yorvipath helps stabilize calcium levels in the blood, reducing the treatment burden associated with managing symptoms through calcium and vitamin D supplements alone.In the realm of pulmonary medicine, Merck’s Winrevair emerged as the first new therapy for pulmonary arterial hypertension (PAH) in over a decade. As the first approved activin-signaling inhibitor therapy, Winrevair represents a novel approach to treating this rare but severe condition that doctors call a “ticking time bomb”. The drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to death within a decade of diagnosis.ARS Pharma launches nasal spray alternative to EpiPen, Eicos introduces med for severe frostbiteLeading the charge in innovative drug delivery is ARS Pharma’s Neffy, the first-ever nasal spray alternative to the EpiPen for treating severe allergic reactions. This groundbreaking advancement represents the first major innovation in anaphylaxis treatment in over a decade. For children and individuals with needle phobia, this nasal spray format addresses one of the most significant barriers to timely treatment of allergic emergencies. Speaking of emergency medicine, Eicos Sciences’ Aurlumyn made history as the first FDA-approved treatment for severe frostbite. This approval fills a critical gap in emergency care, offering a medical intervention that could prevent the need for amputation in severe cases.The cardiovascular space saw its first oral anti-hypertensive therapy that works through a new therapeutic pathway in almost 40 years. Idorsia’s Tryvio is a treatment for hypertension that offers new hope to patients whose blood pressure remains inadequately controlled on existing medications. Idorsia expects millions of patients to benefit from it.Our view This year, the pharmaceutical industry has taken a remarkable leap forward by addressing some of healthcare’s most challenging conditions. Treatments like BMS’ Cobenfy for schizophrenia and Madrigal’s Rezdiffra for MASH demonstrate the industry’s growing ability to translate science into practical therapies. With the growing use of artificial intelligence in the drug industry, we hope that these approvals are just a precursor to a bevy of pathbreaking therapies in the years to come. 
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    https://www.pharmacompass.com/radio-compass-blog/medical-breakthroughs-in-2024-alzheimer-s-schizophrenia-copd-mash-see-pathbreaking-treatments

    #Phispers by PHARMACOMPASS
    14 Nov 2024
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    NEWS #PharmaBuzz

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    Hetero Labs`s Generics Mycophenolate Mofetil Receives Approval in US
    Hetero Labs`s Generics Mycophenolate Mofetil Receives Approval in US

    22 Oct 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208119

    FDA
    22 Oct 2024
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    Hetero Lab`s Generics Milnacipran HCl Receives Approval in US
    Hetero Lab`s Generics Milnacipran HCl Receives Approval in US

    03 Oct 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205147

    FDA
    03 Oct 2024
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    Hetero's Generic Pemetrexed Disodium Receives Approval in the U.S.
    Hetero's Generic Pemetrexed Disodium Receives Approval in the U.S.

    14 Jun 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215460

    FDA
    14 Jun 2024
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    Hetero Labs Generic Ertugliflozin Receives Tentative Approval in US
    Hetero Labs Generic Ertugliflozin Receives Tentative Approval in US

    17 Apr 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217071

    FDA
    17 Apr 2024
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    Hetero's Generic Eszopiclone Receives Approval in the U.S.
    Hetero's Generic Eszopiclone Receives Approval in the U.S.

    04 Jan 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205504

    FDA
    04 Jan 2024
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    Enforcement Report - Week of May 17, 2023
    Enforcement Report - Week of May 17, 2023

    17 May 2023

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-17-2023-88450.pdf

    FDA
    17 May 2023
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    ALL APIs

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    01

    Atomoxetin Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BioFlorida Conference
    Not Confirmed
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    Atomoxetin Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BioFlorida Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20246

    Submission : 2007-02-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-091 - Rev 01

    Issue Date : 2021-03-19

    Type : Chemical

    Substance Number : 2640

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10156

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0021

    Start Marketing Date : 2002-11-26

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Youngjin Pharmaceutical Co., Ltd.

    Registration Date : 2024-05-01

    Registration Number : No. 3838-3-ND(7)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, INDIA

     VMF Others AUDIT
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    02

    Bicalutamide

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BioFlorida Conference
    Not Confirmed
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    Bicalutamide

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BioFlorida Conference
    Not Confirmed
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    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18496

    Submission : 2005-07-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-254 - Rev 02

    Issue Date : 2023-01-09

    Type : Chemical

    Substance Number : 2196

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10046

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2014-02-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0001

    Start Marketing Date : 1995-10-04

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Escitalopram Oxalate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BioFlorida Conference
    Not Confirmed
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    Escitalopram Oxalate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-17

    Pay. Date : 2013-03-07

    DMF Number : 17960

    Submission : 2004-12-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-306 - Rev 00

    Issue Date : 2023-05-23

    Type : Chemical

    Substance Number : 2733

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10125

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2021-08-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0007

    Start Marketing Date : 2002-08-14

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Mirae Pharmchem Co., Ltd.

    Registration Date : 2021-04-21

    Registration Number : 20180604-209-J-223(8)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Survey. No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State India

     VMF Others AUDIT
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    04

    Irbesartan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BioFlorida Conference
    Not Confirmed
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    Irbesartan

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BioFlorida Conference
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-27

    Pay. Date : 2016-05-12

    DMF Number : 17507

    Submission : 2004-07-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-104 - Rev 04

    Issue Date : 2024-03-25

    Type : Chemical

    Substance Number : 2465

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10007

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2016-01-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0005

    Start Marketing Date : 1997-09-30

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Lamivudine

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BioFlorida Conference
    Not Confirmed
    arrow

    Lamivudine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BioFlorida Conference
    Not Confirmed
    • fda
    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-27

    Pay. Date : 2012-12-03

    DMF Number : 18252

    Submission : 2005-04-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-168 - Rev 01

    Issue Date : 2024-05-02

    Type : Chemical

    Substance Number : 2217

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10157

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0016

    Start Marketing Date : 1995-11-17

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    06

    Levetiracetam

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BioFlorida Conference
    Not Confirmed
    arrow

    Levetiracetam

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BioFlorida Conference
    Not Confirmed
    • fda
    • EDQM
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-30

    DMF Number : 17738

    Submission : 2004-10-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-113 - Rev 01

    Issue Date : 2021-07-19

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10091

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2020-07-29

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0006

    Start Marketing Date : 1999-11-30

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Myungin Pharmaceutical Co., Ltd.

    Registration Date : 2017-08-03

    Registration Number : 20120210-183-I-21-19(6)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, India

     VMF Others AUDIT
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    07

    Lisinopril

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BioFlorida Conference
    Not Confirmed
    arrow

    Lisinopril

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BioFlorida Conference
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    • fda
    • EDQM
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-11

    Pay. Date : 2012-11-29

    DMF Number : 16510

    Submission : 2003-03-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-197 - Rev 02

    Issue Date : 2024-07-03

    Type : Chemical

    Substance Number : 1120

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10145

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA

    Initial Date of Registration : 2010-04-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-04

    Valid Till : 2025-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0009

    Start Marketing Date : 1987-12-29

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    08

    Losartan Potassium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BioFlorida Conference
    Not Confirmed
    arrow

    Losartan Potassium

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BioFlorida Conference
    Not Confirmed
    • fda
    • EDQM
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-30

    Pay. Date : 2013-04-23

    DMF Number : 19988

    Submission : 2006-11-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-247 - Rev 08

    Issue Date : 2023-07-04

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10096

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2021-06-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0008

    Start Marketing Date : 1995-04-14

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Olanzapine

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BioFlorida Conference
    Not Confirmed
    arrow

    Olanzapine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BioFlorida Conference
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-24

    Pay. Date : 2013-12-10

    DMF Number : 20591

    Submission : 2007-06-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-215 - Rev 00

    Issue Date : 2019-01-29

    Type : Chemical

    Substance Number : 2258

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10065

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA

    Initial Date of Registration : 2015-03-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-04

    Valid Till : 2025-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0026

    Start Marketing Date : 1996-09-30

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2021-05-18

    Registration Number : 20210518-209-J-928

    Manufacturer Name : Hetero Drugs Limited Unit I

    Manufacturer Address : Survey. No. 213, 214 and 255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Telangana State, India

     VMF Others AUDIT
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    10

    Quetiapine Hemifumarate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BioFlorida Conference
    Not Confirmed
    arrow

    Quetiapine Hemifumarate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BioFlorida Conference
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-23

    Pay. Date : 2013-07-12

    DMF Number : 20845

    Submission : 2007-09-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-153 - Rev 02

    Issue Date : 2023-06-15

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10094

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2016-04-27

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0024

    Start Marketing Date : 1997-09-26

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Mirae Pharmchem Co., Ltd.

    Registration Date : 2021-07-05

    Registration Number : 20120816-172-I-120-06(2)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Medak District, Telangana, INDIA

     VMF Others AUDIT
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    USDMF

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    01

    Abacavir Sulfate

    India
    The Pharmacy Technology
    Not Confirmed
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    Abacavir Sulfate

    India
    arrow
    The Pharmacy Technology
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    Hetero Drugs

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-02-15

    Pay. Date : 2013-01-24

    DMF Number : 22196

    Submission : 2008-11-17

    Status : Active

    Type : II

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    02

    Abacavir Sulfate (process-ii), Usp

    India
    The Pharmacy Technology
    Not Confirmed
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    03

    Abiraterone Acetate

    India
    The Pharmacy Technology
    Not Confirmed
    arrow

    04

    Acyclovir

    India
    The Pharmacy Technology
    Not Confirmed
    arrow

    Acyclovir

    India
    arrow
    The Pharmacy Technology
    Not Confirmed
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    Hetero Drugs

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-10

    DMF Number : 25587

    Submission : 2011-12-13

    Status : Active

    Type : II

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    05

    Afatinib Dimaleate

    India
    The Pharmacy Technology
    Not Confirmed
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    Afatinib Dimaleate

    India
    arrow
    The Pharmacy Technology
    Not Confirmed
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    Hetero Drugs

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-05-30

    Pay. Date : 2017-04-28

    DMF Number : 31611

    Submission : 2017-04-11

    Status : Active

    Type : II

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    06

    Afatinib Dimaleate (form A)

    India
    The Pharmacy Technology
    Not Confirmed
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    07

    Alectinib Hydrochloride

    India
    The Pharmacy Technology
    Not Confirmed
    arrow

    08

    Alfuzosin Hydrochloride

    India
    The Pharmacy Technology
    Not Confirmed
    arrow

    09

    Allopurinol

    India
    The Pharmacy Technology
    Not Confirmed
    arrow

    Allopurinol

    India
    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Hetero Drugs

    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-03-17

    Pay. Date : 2020-12-17

    DMF Number : 35422

    Submission : 2020-12-21

    Status : Active

    Type : II

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    Market
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    10

    Amifampridine Phosphate

    India
    The Pharmacy Technology
    Not Confirmed
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    LISTED APIs

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    Abacavir

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    01

    Abacavir

    India
    euroPLX 86 Munich
    Not Confirmed
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    Abacavir

    India
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    euroPLX 86 Munich
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Abiraterone

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    02

    Abiraterone

    India
    euroPLX 86 Munich
    Not Confirmed
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    Abiraterone

    India
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    euroPLX 86 Munich
    Not Confirmed
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Acalabrutinib

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    03

    Acalabrutinib

    India
    euroPLX 86 Munich
    Not Confirmed
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    Acalabrutinib

    India
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    euroPLX 86 Munich
    Not Confirmed
    • fda
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Aciclovir

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Aciclovir

    India
    euroPLX 86 Munich
    Not Confirmed
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    Aciclovir

    India
    arrow
    euroPLX 86 Munich
    Not Confirmed
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

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    Adefovir Dipivoxil

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Adefovir Dipivoxil

    India
    euroPLX 86 Munich
    Not Confirmed
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    Adefovir Dipivoxil

    India
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    euroPLX 86 Munich
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Afatinib

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Afatinib

    India
    euroPLX 86 Munich
    Not Confirmed
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    Afatinib

    India
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    Hetero Drugs

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    Alectinib Hydrochloride

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    07

    Alectinib Hydrochloride

    India
    euroPLX 86 Munich
    Not Confirmed
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    Hetero Drugs

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    Alfuzosin HCl

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Alfuzosin HCl

    India
    euroPLX 86 Munich
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    Alfuzosin HCl

    India
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    euroPLX 86 Munich
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Alogliptin Benzoate

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Alogliptin Benzoate

    India
    euroPLX 86 Munich
    Not Confirmed
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    Alogliptin Benzoate

    India
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

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    Alpelisib

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Alpelisib

    India
    euroPLX 86 Munich
    Not Confirmed
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    Alpelisib

    India
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    euroPLX 86 Munich
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    FDA Orange Book

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    01

    Brand Name : ABACAVIR SULFATE

    India
    BioFlorida Conference
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
    BioFlorida Conference
    Not Confirmed
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    RLD : No

    TE Code : AB

    ABACAVIR SULFATE

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : EQ 300MG BASE

    Approval Date : 2013-09-13

    Application Number : 91560

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    02

    Brand Name : ABACAVIR SULFATE

    India
    BioFlorida Conference
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
    BioFlorida Conference
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    RLD : No

    TE Code : AA

    ABACAVIR SULFATE

    Hetero Drugs

    Dosage Form : SOLUTION; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : EQ 20MG BASE/ML

    Approval Date : 2016-09-26

    Application Number : 201107

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

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    03

    Brand Name : ABACAVIR SULFATE; LA...

    India
    BioFlorida Conference
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE; LA...

    India
    BioFlorida Conference
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE; LAMIVU...

    Dosage Strength : 600;300MG

    Approval Date :

    Application Number : 205412

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    04

    Brand Name : ABACAVIR; LAMIVUDINE

    India
    BioFlorida Conference
    Not Confirmed
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    Brand Name : ABACAVIR; LAMIVUDINE

    India
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    RLD :

    TE Code :

    ABACAVIR; LAMIVUDINE

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR; LAMIVUDINE

    Dosage Strength : 60MG;30MG

    Approval Date :

    Application Number : 207369

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    05

    Brand Name : ACYCLOVIR

    India
    BioFlorida Conference
    Not Confirmed
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    Brand Name : ACYCLOVIR

    India
    BioFlorida Conference
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 400MG

    Approval Date : 2013-10-29

    Application Number : 203834

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    06

    Brand Name : ACYCLOVIR

    India
    BioFlorida Conference
    Not Confirmed
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    Brand Name : ACYCLOVIR

    India
    BioFlorida Conference
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 800MG

    Approval Date : 2013-10-29

    Application Number : 203834

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    07

    Brand Name : ACYCLOVIR

    India
    BioFlorida Conference
    Not Confirmed
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    Brand Name : ACYCLOVIR

    India
    BioFlorida Conference
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Hetero Drugs

    Dosage Form : SUSPENSION; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 200MG/5ML

    Approval Date : 2022-07-01

    Application Number : 215669

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    08

    Brand Name : ALLOPURINOL

    India
    BioFlorida Conference
    Not Confirmed
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    Brand Name : ALLOPURINOL

    India
    BioFlorida Conference
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    RLD : No

    TE Code : AB

    ALLOPURINOL

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALLOPURINOL

    Dosage Strength : 100MG

    Approval Date : 2023-08-03

    Application Number : 217748

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    09

    Brand Name : ALLOPURINOL

    India
    BioFlorida Conference
    Not Confirmed
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    Brand Name : ALLOPURINOL

    India
    BioFlorida Conference
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    RLD : No

    TE Code : AB

    ALLOPURINOL

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALLOPURINOL

    Dosage Strength : 300MG

    Approval Date : 2023-08-03

    Application Number : 217748

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    Brand Name : AMLODIPINE BESYLATE ...

    India
    BioFlorida Conference
    Not Confirmed
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    Brand Name : AMLODIPINE BESYLATE ...

    India
    BioFlorida Conference
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    RLD : No

    TE Code : AB

    AMLODIPINE BESYLATE; VALSARTAN

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMLODIPINE BESYLATE AND ...

    Dosage Strength : EQ 5MG BASE;160MG

    Approval Date : 2016-09-16

    Application Number : 205137

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Only 10 entries up to this point, click to access all click full view read-more
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    South Africa

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    01

    Brand Name : VUTERAR

    India
    American Pharma Summit
    Not Confirmed
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    Brand Name : VUTERAR

    India
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    American Pharma Summit
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Hetero Drugs

    Dosage Form : TAB

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Brand Name : VUTERAR

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    02

    Brand Name : VUTERAR

    India
    American Pharma Summit
    Not Confirmed
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    Brand Name : VUTERAR

    India
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    American Pharma Summit
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Hetero Drugs

    Dosage Form : TAB

    Dosage Strength : 600mg

    Packaging : 90X1mg

    Brand Name : VUTERAR

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    03

    Brand Name : Hetbaclam

    India
    American Pharma Summit
    Not Confirmed
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    Brand Name : Hetbaclam

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Hetero Drugs

    Dosage Form : FCT

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Brand Name : Hetbaclam

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Market
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    04

    Brand Name : Heteruam 600/300 mg

    India
    American Pharma Summit
    Not Confirmed
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    Brand Name : Heteruam 600/300 mg

    India
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    American Pharma Summit
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Hetero Drugs

    Dosage Form : FCT

    Dosage Strength : 600mg

    Packaging : 28X1mg

    Brand Name : Heteruam 600/300 mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    05

    Brand Name : Heteruam 600/300 mg

    India
    American Pharma Summit
    Not Confirmed
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    Brand Name : Heteruam 600/300 mg

    India
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    American Pharma Summit
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Hetero Drugs

    Dosage Form : FCT

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Brand Name : Heteruam 600/300 mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Market
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    06

    Brand Name : Hetacav Oral Solutio...

    India
    American Pharma Summit
    Not Confirmed
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    Brand Name : Hetacav Oral Solutio...

    India
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    American Pharma Summit
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir Sulphate

    Hetero Drugs

    Dosage Form : SOL

    Dosage Strength : 20mg/ml

    Packaging : 240X1mg/ml

    Brand Name : Hetacav Oral Solution Hetero ...

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    07

    Brand Name : Hetacav 300

    India
    American Pharma Summit
    Not Confirmed
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    Brand Name : Hetacav 300

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir Sulphate

    Hetero Drugs

    Dosage Form : FCT

    Dosage Strength : 300mg

    Packaging : 60X1mg

    Brand Name : Hetacav 300

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Market
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    08

    Brand Name : Heteran 250

    India
    American Pharma Summit
    Not Confirmed
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    Brand Name : Heteran 250

    India
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    Not Confirmed
    • fda
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    Abiraterone Acetate

    Hetero Drugs

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    Anastrozole

    Hetero Drugs

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    Bendamustine Hydrochloride

    Hetero Drugs

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    Hetero Drugs is a supplier offers 493 products (APIs, Excipients or Intermediates).

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